Is there room for improvement in adverse event reporting in the era of targeted therapies?

J Natl Cancer Inst. 2008 Feb 20;100(4):240-2. doi: 10.1093/jnci/djm324. Epub 2008 Feb 12.

Abstract

The Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, and its predecessors, the Common Toxicity Criteria (CTC) versions 1.0 and 2.0, were developed under the direction of the Cancer Therapy Evaluation Program of the National Cancer Institute (NCI) in an effort to provide standard language for reporting adverse events that occur in NCI-sponsored clinical trials. Each successive version of the CTC has improved the accuracy, precision, and completeness of the criteria in an effort to standardize reporting. We believe that the current version of the CTCAE cannot adequately code the subacute adverse events that commonly occur with today's targeted therapies.

MeSH terms

  • Adverse Drug Reaction Reporting Systems / standards*
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects*
  • Clinical Trials as Topic / methods*
  • Humans
  • National Cancer Institute (U.S.)
  • Neoplasms / drug therapy*
  • Outcome Assessment, Health Care*
  • Research Design* / trends
  • Surveys and Questionnaires
  • United States

Substances

  • Antineoplastic Agents